» Guided Surgery. by MEDENTiKA « MEDENTIGUIDE SURGERY MANUAL QUATTROCONE QUATTROCONE30. IPS Implant systems

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1 » Guided Surgery by MEDENTiKA «IPS Implant systems MEDENTIGUIDE QUATTROCONE QUATTROCONE30 SURGERY MANUAL

2 » MedentiGuide «MedentiGuide drill sleeves support the surgeon in preparing the implant bed for MEDENTiKA implants. Their use must be planned with a specially designed 3D planning system and surgical drilling template. You can plan the surgery with standard planning programs. Treatment planning based on three dimensional imaging procedures (CT, DVT) enables high precision treatment planning and means that the treatment outcome can be accurately predicted. These software manufacturers* currently support the MedentiGuide System The advantages over conventional planning include: Precision three-dimensional planning and implantation, taking into account the desired restoration Automatic collision control that displays if the distances to the implants or nerves are too short Information on peri-implant bone quality so that conclusions can be drawn on the expected primary stability An individual drilling template can be produced on the basis of the digital planning data. This ensures the exact and precise transfer of the planning outcome to the patient s mouth. Note: MEDENTiKA GmbH accepts no liability for the correct planning, implementation and production of the drilling template. Sufficient knowledge of the 3D planning system being used and the MEDENTiKA implant system is essential. It is imperative that the user is very confident in the use of 3D planning systems before using the MedentiGuide drill sleeves. Furthermore, sufficient expertise in preoperative implant planning and dental implantology is required. * to some extent this depends on the availability of the updates of the specific manufacturer. 2 3

3 SYSTEM DESCRIPTION» Drilling template MedentiGuide An individual drilling template can be produced on the basis of the digital planning data. This ensures the exact and precise application of the planning outcome to the patient s mouth. MedentiGuide drill sleeves can be used in drill sleeves of various designs. The templates may be produced using suitable milling or printing systems with CADCAM technology or using alternative procedures. Insertion tool «The appropriate insertion tool is used to ensure that the outer sleeve is inserted securely into the template. NB: The drilling template must be firmly and securely seated on the jaw with no gaps. Drilling template with inserted outer sleeves Drilling template with inserted outer and innner sleeves 4 5

4 SYSTEM DESCRIPTION» Surgical Tray Drill lengths «QUATTROCONE QUATTROCONE30 Easy to use: No additional surgical tray is required with the MedentiGuide drill sleeve system. The drill sleeves are adapted to the Quattrocone standard drill. This significantly simplifies the preparation of the implantation and considerably reduces the material and storage costs. The MedentiGuide insertion tools are optionally available to guide the implants through the drill sleeves. The MedentiGuide System supports two drill lengths: 20 mm and 25 mm. In the planning phase it is important to ensure that the correct drill length is selected. PLEASE NOTE: The MedentiGuide drill sleeves are only designed for standard drills. The defined drilling depths do not include the drill tip of 0.2 mm. Please note their lengths if only minimum space is available to anatomical structures. Example for D 3.5 mm Implant: Standard drill Ø 3.2 mm Bone quality D3 / D4 TWO DRILL LENGTHS: Short drill 1 marking ring Long drill 2 marking rings Total length 35.3 mm 20 mm Total length 40.3 mm 25 mm 0.2 mm drill tip 0.2 mm drill tip 6 7

5 SYSTEM DESCRIPTION» Sleeve in sleeve «QUATTROCONE QUATTROCONE30 MEDENTIGUIDE DRILL SLEEVES Locks in the rotational direction of the drill The inner sleeves are colour-matched to the corresponding colour-coded implants for easy recognition. Sleeve Art. No. Description Outer diameter Inner diameter Implant diameter Drill Standard outer sleeve Large outer sleeve Adapter sleeve D 6.3 d 5.03 D mm D 8.3 d 7.03 D 5.0 mm D 7.0 d 5.03 D 5.0 mm Inner sleeve D 5.0 d 2.03 Pilot Inner sleeve D 5.0 d 3.23 D 3.5 mm MedentiGuide Drill Sleeves are a sleeve in sleeve system made up of various outer sleeves and matching inner sleeves. MedentiGuide drill sleeves can be used in drill sleeves of various designs Inner sleeve D 5.0 d Inner sleeve D 7.0 d 4.73 D 4.3 mm D 5.0 mm The templates may be produced using suitable milling or printing systems with CADCAM technology or using alternative procedures. The MedentiGuide Sleeve System works with bayonet lock. The lock engages clockwise and thus in the rotational direction of the drill. 8 9

6 SYSTEM DESCRIPTION» MICROCONE implants D mm QUATTROCONE30 implants 4.3 mm QUATTROCONE Implants D 5.0 mm QUATTROCONE30 Implants D 5.0 mm «d 2.02 d 2.02 Inner sleeve e.g. pilot drills H 5.0 mm H 5.0 mm D 5.0 mm Inner sleeve e.g. pilot drills d 5.03 D 5.0 mm The standard outer sleeve is used in conjunction with the QUATTROCONE implants D D 4.3. Standard outer sleeve For implants measuring D d 5.03 mm D 6.3 mm H 4.0 mm H 4.0 mm H 3.0 mm D 7.0 mm d 7.03 mm Adapter sleeve To hold the standard inner sleeve Large outer sleeve For implants measuring D 5.0 The large outer sleeve must be used for the Quattrocone implants D 5.0. D 8.3 mm QUATTROCONE IMPLANTS D D 4.3 MM QUATTROCONE IMPLANTS D 5.0 MM Pilot D D Pilot D D Inner sleeve D Adapter sleeve Standard outer sleeve Large outer sleeve Large outer sleeve

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8 SYSTEM DESCRIPTION» Selection of drill length «QUATTROCONE The MedentiGuide System software supports the standard drill with two drill lengths: 20 mm and 25 mm. The distance from the top edge of the inner sleeve to the bottom edge of the implant is thus defined by the selected drill length. The distance between the lower edge of the outer sleeve and the top edge of the implant is always defined by the selected implant and drill lengths. The distance between the lower edge of the sleeve and the upper edge of the implant can be defined, depending on the desired implant length, by the choice of the drill length. NB: The desired drill length must therefore be taken into account during planning. Long drill Short drill 1 mm 4 mm 1 mm 4 mm 9 mm 4 mm 25 mm 20 mm 11 mm 11 mm 14 15

9 SYSTEM DESCRIPTION» MedentiGuide Placement instrument«quattrocone The implants can optionally be guided through the template for positioning. This involves the use of the corresponding MedentiGuide placement instruments, either for manual and ratchet or the contra-angled handpiece. The drill length determines whether the short or long MedentiGuide placement instrument is used. Long drill Short drill Short drill & MedentiGuide placement instrument, short >> 1 marking ring Long drill & MedentiGuide placement instrument, long >> 2 markings rings 16 17

10 SYSTEM DESCRIPTION» MedentiGuide Placement instrument Implant alignment «QUATTROCONE MedentiGuide placement instrument, short To ensure that the implant is inserted at the correct height, it is rotated through the outer sleeve until the corresponding depth marker is flush with the top edge of the outer sleeve. 1 mm 4 mm Depth marker for implant length 11 mm If required, the implants can be aligned to the indexing of the implant connection. The MedentiGuide placement instrument is used in this case. The vertical marking on the placement instrument is aligned in the direction of the area of the square in the implant. The marking/notch on the outer sleeve is used as a guide to correctly position the implant. 20 mm 4 mm 11 mm Implant length 11 mm MedentiGuide Placement Instrument, long 1 mm 4 mm Depth marker for implant length 15 mm 5 mm 25 mm 15 mm Implant length 15 mm 18 19

11 » QUATTROCONE «drilling protocol (For example, for D 4.3 x 11 mm implant with the standard outer sleeve) Initial situation Pilot hole with the Ø 2.0 mm pilot drill Deep drilling with the final standard drill Ø 2.0 / 3.2 / 4.0 mm Insert the implant either by hand/ ratchet or with the contra-angled handpiece. Submerged or transgingival healing can be achieved Cut a flap in the soft tissue to expose the bone around the implantation point or optionally expose the implantation point with the mucosal punch. NB: Check the drilling template at every step to ensure that it is correctly seated. It is important to observe the surgical manual for each implant system. The pilot hole is made with the Ø 2.0 mm pilot drill. Guided by the drill sleeve (inner sleeve), this defines the sagittal direction of the implant axis and the drilling depth. The recommended speed is rpm and the maximum speed is 800 rpm. Incremental drilling is performed with the corresponding drill sleeve (inner sleeve), in this case with the D 2.0/3.2/4.0 mm standard drill. The recommended speed is rpm and the maximum speed is 800 rpm. NB: Before inserting the implant, the inner sleeve must be removed. The implant is then screwed in position through the outer sleeve until the depth marking of the placement instrument is flush with the upper edge of the outer sleeve. Check the vertical marking on the placement instrument to ensure the desired alignment of the implant connection. The implant can heal either with submerged or transgingival methods

12 » QUATTROCONE «drilling protocol (For example, for D 5.0 x 15 mm implant with the large outer sleeve) Initial situation Pilot hole with the Ø 2.0 mm pilot drill Optional interval drilling with the standard drill Ø 2.0 / 3.2 / 4.0 mm Deep drilling with the final Ø 3.2 / 4.0 / 4.7 mm standard drill Insert the implant either by hand/ratchet or with the contra-angled handpiece. Submerged or transgingival healing can be achieved Cut a flap in the soft tissue to expose the bone around the implantation point or optionally expose the implantation point with the mucosal punch. NB: Check the drilling template at every step to ensure that it is correctly seated. It is important to observe the surgical manual for each implant system. The pilot hole is made with the Ø 2.0 mm pilot drill. Guided by the drill sleeve (adapter sleeve and the corresponding internal sleeve), this defines the sagittal direction of the implant axis and the drilling depth. The recommended speed is rpm and the maximum speed is 800 rpm. Incremental drilling is performed with the appropriate drill sleeve (adapter sleeve and internal sleeve), in this case with the D 2.0/3.2/4.0 mm standard drill. The recommended speed is rpm and the maximum speed is 800 rpm. The adapter sleeve is now removed with the inner sleeve from the previous drilling. The inner sleeve ( ) for the final drilling is then inserted into the external sleeve. To achieve the final depth, drilling is performed with the final drill, which in this case is the standard drill D 3.2/4.0/4.7 mm. The recommended speed is rpm and the maximum speed is 800 rpm. NB: Before screwing the D 5.0 implant into position, the inner sleeve has to be replaced with the adapter sleeve. Now the implant is screwed through the outer sleeve until the depth marking of the placement instrument is flush with the upper edge of the adapter sleeve. Check the vertical marking on the placement instrument to ensure the desired alignment of the implant connection. The implant can heal either with submerged or transgingival methods

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14 SYSTEM DESCRIPTION» Selection of drill length «QUATTROCONE30 The MedentiGuide System software supports the standard drill with two drill lengths: 20 mm and 25 mm. The distance from the top edge of the inner sleeve to the bottom edge of the implant is thus defined by the selected drill length. The distance between the lower edge of the outer sleeve and the top edge of the implant is always defined by the selected implant and drill lengths. The distance between the lower edge of the sleeve and the upper edge of the implant can be defined, depending on the desired implant length, by the choice of the drill length. NB: The desired drill length must therefore be taken into account during planning. Long drill Short drill 1 mm 4 mm 1 mm 4 mm 7 mm 2 mm 25 mm 20 mm 13 mm 13 mm 26 27

15 SYSTEM DESCRIPTION» MedentiGuide Placement instrument «QUATTROCONE30 The implants can optionally be guided through the template for positioning. This involves the use of the corresponding MedentiGuide placement instruments, either for manual and ratchet or the contra-angled handpiece. The drill length determines whether the short or long MedentiGuide placement instrument is used. Long drill Short drill Short drill & MedentiGuide placement instrument, short >> 1 marking ring Long drill & MedentiGuide placement instrument, long >> 2 marking rings 28 29

16 SYSTEM DESCRIPTION» MedentiGuide Placement instrument Implant alignment QUATTROCONE30 «MedentiGuide placement instrument, short To ensure that the implant is inserted at the correct height, it is rotated through the outer sleeve until the corresponding depth marker is flush with the top edge of the outer sleeve. 20 mm 1 mm 4 mm 6 mm Depth marker for implant length 9 mm The Quattrocone30 implants must be aligned to match the indexing of the implant connection (label AI). This is because there is only one possible position for the Quattrocone30 implants, due to their 30 angled implant shoulder. This is achieved with the corresponding MedentiGuide Placement Instrument labeled AI Q. The vertical marking on the placement instrument is aligned in the direction of the short side of the implant. The marking/notch on the outer sleeve is used as a guide to correctly position the implant. 9 mm MedentiGuide Placement Instrument, long 1 mm 4 mm Depth marker for implant length 13 mm 7 mm 25 mm 13 mm 30 31

17 » QUATTROCONE30 «drilling protocol (Example for D 4.3 x 13 mm implant with the standard outer sleeve when using the All-On-4 * or QuattroFix) *All-On-4 is a registered trademark of Nobel Biocare. Initial situation Pilot hole with the Ø 2.0 mm pilot drill Deep drilling with the final Ø 2.0 / 3.2 / 4.0 mm standard drill Insert the implant either by hand/ratchet or with the contra-angled handpiece. Submerged or transgingival healing can be achieved Cut a flap in the soft tissue to expose the bone around the implantation point or optionally expose the implantation point with the mucosal punch. NB: Check the drilling template at every step to ensure that it is correctly seated. It is important to observe the surgical manual for each implant system. The pilot hole is drilled with the Ø 2.0 mm pilot drill. Guided by the drill sleeve (inner sleeve), this defines the sagittal direction of the implant axis and the drilling depth. The recommended speed is rpm and the maximum speed is 800 rpm. Incremental drilling is performed with the corresponding drill sleeve (inner sleeve), in this case with the D 2.0/3.2/4.0 mm standard drill. The recommended speed is rpm and the maximum speed is 800 rpm. NB: Before inserting the implant, the inner sleeve must be removed. The implant is then screwed in position through the outer sleeve until the depth marking of the placement instrument is flush with the upper edge of the outer sleeve. The vertical marking of the placement instrument must be observed to ensure the necessary alignment of the implant connection. The implant can heal either with submerged or transgingival methods

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19 36» Surgery Surgery «37 MedentiGuide Outer sleeve standard Titanium Grade 5 CF MedentiGuide Placement instrument Implant Manual and ratchet Stainless steel Diameter (mm) D 6.3 / d 5.03 Article No Please note: This sleeve is used for implants D D 4.5. Implant connection RI RI AI AI Type Quattrocone Quattrocone Quattrocone30 Quattrocone30 Version short long short long Article No Please note: These insertion tools are used to insert implants when using MedentiGuide sleeves. MedentiGuide Outer sleeve large Titanium Grade 5 CF MedentiGuide Placement instrument Implant Contra-angle Stainless steel MedentiGuide Adapter sleeve Titanium Grade 5 CF Diameter (mm) D 8.3 / d 7.03 Article No Please note: This sleeve is used for implants D 5.0. Implant connection RI RI AI AI Type Quattrocone Quattrocone Quattrocone30 Quattrocone30 Version short long short long Article No Please note: These insertion tools are used to insert implants when using MedentiGuide sleeves. MedentiGuide Inner sleeve Quattrocone Implant Titanium Grade 5 CF Diameter (mm) D 7.0 / d 5.03 Article No Please note: This sleeve is used as a connecting piece between the Outer sleeve large and the Inner sleeves for the drill diameter D D 4.0. Placement instrument MedentiGuide Stainless steel Diameter (mm) D 5.0 / d 2.03 D 5.0 / d 3.23 D 5.0 / d 4.03 D 7.0 / d 4.73 Colour code grey pink purple brown Drill diameter D 2.0 mm D 3.2 mm D 4.0 mm D 4.7 mm Article No Type Outer sleeve standard Outer sleeve large Article No

20 Publisher: MEDENTiKA GmbH Hammweg Hügelsheim Tel: +49 (0) Design: The WeberFink GbR graphic design studio Date: August 2018 We are certified according to: DIN EN ISO13485:2012 Medical Devices Directive 93/42/EEC, Annex II Subject to modification without notice. Errors and omissions excepted. The instructions for use and guarantee conditions are available on the website Please contact the manufacturer directly for further information concerning the guarantee.

21 MEDENTiKA GmbH Hammweg Hügelsheim MEDENTiKA always well-treated «